RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.

The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move
across top level links and expand / close menus in sub levels. Up and Down arrows will open main level
menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab
will move on to the next part of the site rather than go through menu items.

About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

At least nine US House and Senate bills introduced in March would impact the pharmaceutical industry, including three to allow for more prescription drug imports from Canada, pharmacy benefit management (PBM) transparency and one on cost sharing for cancer medicines.

With regard to importation, Rep. Elijah Cummings (D-MD) introduced a bill seeking to allow an increase of less costly medicines from Canada and Sen. Bernie Sanders (D-VT) introduced a similar measure.

Cummings met with President Donald Trump to discuss the bill on 8 March, and a White House readout of the meeting noted: “Reforming the Food and Drug Administration and reducing the regulatory burdens on drug manufacturers so as to enhance competition will help accomplish” goals discussed, including ensuring “prescription drug prices are more affordable for all Americans.”

Cost Sharing

The bill says: “A group health plan, and a health insurance issuer offering group or individual health insurance coverage, that provides benefits with respect to anticancer medications administered by a health care provider shall provide that any cost sharing for prescribed, patient-administered anticancer medications that are used to kill, slow, or prevent the growth of cancerous cells and that have been approved by the Food and Drug Administration is no less favorable than the cost sharing for anticancer medications that is intravenously administered or injected by a health care provider.”

Previously introduced in 2015, Lance said the bill is meant to help patients who are using cancer treatments “but are forced to pay astronomical out-of-pocket costs or forgo treatment altogether.”

PBMs

Under the Prescription Drug Price Transparency Act, introduced 2 March by Rep. Doug Collins (R-GA), PBMs would be prevented from requiring that enrollees use a particular pharmacy “or provide an incentive to a plan enrollee to encourage the enrollee” to use a certain pharmacy.

The bill would also require the disclosure to the applicable pharmacies “all individual drug prices to be so updated in advance of the use of such prices for the reimbursement of claims.”

Other Bills

Both the Senate and the House seek to reauthorize a program for early detection, diagnosis and treatment regarding deaf and hard-of-hearing newborns, infants and young children.

And two others (Senate and House) look to minimize the development of antibiotic-resistant bacteria.

Rep. Jose Serrano (D-NY) also introduced a bill to amend the Federal Food, Drug, and Cosmetic Act to “ensure that liquid over-the-counter medications are packaged with appropriate dosage delivery devices and, in the case of such medications labeled for pediatric use, appropriate flow restrictors, and for other purposes.”